K-Phos Original

Generic Name: phosphate supplement (Oral route, Parenteral route)

Commonly used brand name(s):

In the U.S.

• Fleet Phospho-soda EZ-Prep
• K-Phos Original
• OsmoPrep
• Phospho-Soda
• Visicol

Available Dosage Forms:

• Tablet
• Tablet, Enteric Coated
• Liquid

Uses For K-Phos Original

Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.

Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.

The daily amount of phosphorus needed is defined in several different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:

Before Using K-Phos Original

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

• Amantadine
• Atropine
• Belladonna
• Belladonna Alkaloids
• Benztropine
• Biperiden
• Clidinium
• Dicyclomine
• Dronedarone
• Eplerenone
• Glycopyrrolate
• Hyoscyamine
• Methscopolamine
• Oxybutynin
• Procyclidine
• Scopolamine
• Solifenacin
• Tolterodine
• Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Asenapine
• Benazepril
• Canrenoate
• Captopril
• Cilazapril
• Delapril
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Iloperidone
• Imidapril
• Indomethacin
• Lapatinib
• Lisinopril
• Lumefantrine
• Methadone
• Moexipril
• Nilotinib
• Pazopanib
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Ranolazine
• Spirapril
• Spironolactone
• Sunitinib
• Telavancin
• Temocapril
• Tetrabenazine
• Trandolapril
• Triamterene
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Burns, severe or
• Heart disease or
• Pancreatitis (inflammation of the pancreas) or
• Rickets or
• Softening of bones or
• Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse.

• Dehydration or
• Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

• Edema (swelling in feet or lower legs or fluid in lungs) or
• High blood pressure or
• Liver disease or
• Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse.

• High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse.

• Infected kidney stones—Phosphates may make this condition worse.

• Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

• Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse.

Proper Use of phosphate supplement

This section provides information on the proper use of a number of products that contain phosphate supplement. It may not be specific to K-Phos Original. Please read with care.

For patients taking the tablet form of this medicine:

• Do not swallow the tablet. Before taking, dissolve the tablet in ¾ to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:

• Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2½ ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:

• Add the entire contents of 1 bottle (2¼ ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved.
• Do not dilute solution further.
• This solution may be chilled to improve the flavor; do not allow it to freeze.
• Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.

To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For potassium phosphates
• For oral dosage form (solution):
  • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
    • Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
  • To replace phosphorus lost by the body:
    • Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
    • Children up to 4 years of age—The dose must be determined by your doctor.
• For oral dosage forms (capsules or oral solution):
  • To replace phosphorus lost by the body:
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
    • Children up to 4 years of age—Dose must be determined by your doctor.
• For oral dosage forms (powder for oral solution):
  • To replace phosphorus lost by the body:
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
    • Children up to 4 years of age—Dose must be determined by your doctor.

• For potassium and sodium phosphates
• For oral dosage form (solution):
  • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
    • Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
  • To replace phosphorus lost by the body:
    • Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
    • Children up to 4 years of age—Dose must be determined by your doctor.
• For oral dosage forms (capsules or solution):
  • To replace phosphorus lost by the body:
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
    • Children up to 4 years of age—Dose must be determined by your doctor.
• For oral dosage forms (powder for solution):
  • To replace phosphorus lost by the body:
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
    • Children up to 4 years of age—Dose must be determined by your doctor.
• For oral dosage forms (tablets for solution):
  • To replace phosphorus lost by the body:
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day.
    • Children up to 4 years of age—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using K-Phos Original

Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.

For patients taking potassium phosphate-containing medicines:

• Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:

• This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional.
• Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:

• This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional.

K-Phos Original Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Confusion
• convulsions (seizures)
• decrease in amount of urine or in frequency of urination
• fast, slow, or irregular heartbeat
• headache or dizziness
• increased thirst
• muscle cramps
• numbness, tingling, pain, or weakness in hands or feet
• numbness or tingling around lips
• shortness of breath or troubled breathing
• swelling of feet or lower legs
• tremor
• unexplained anxiety
• unusual tiredness or weakness
• weakness or heaviness of legs
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea or vomiting
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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